p . 1 BT Study Number: B04109

Report After the classification, an Identification card (stated test no ., group/dose, individual no ., sex, administration route, administration period, date of necropsy and etc .) was attached on a cage . To identify between animals, their tails were labeled using an oil base magic pen in accordance with the method of identification (SOP/SGE/140) . 4 . Experimental condition s (1) Room No . A319 (2) Type and size of a cag e The animals were housed individually in stainless steel wire cages (A polycarbonate cage (260W X 420L x 180H (mm), Deajong machinery ) (3) Number of animals in a cag e 8-9 (quarantine and acclimatization period)/6(main test) (4) Temperature 21 .26 - 22 .44 'C (5) Relative humidity 43 .73 - 50 .78 % (6) Method of ventilation and frequency 10--15/hr , (7) Artificial lighting : the sequence being 12 hours light (a .m . 7 :00-p .m . 7 :00) and 12 hours dark (p .m . 7 :00-a .m . 7 :00) (8) Illumination intensity 150 - 300 Lux (9) Rinsing and sterilization of breeding materials and animal roo m A 500 fold solution of alkali surface active agent (Ultra-Clean Neighbour-PC, NE-SARANG CO .,Ltd .) and 2500 fold solution of surface active aQent (Ultra-Clean Neighbour-RM300, NE-SARANG Co .,Ltd .) will be used for rinsing~a cage ; and high pressure steam will be used for a sterilization . A Cage, water supply bottle, and fodder supplier will be replaced after the acclimatization period
. After the daily work, Pacorn-A (the principal element : 200 fold Octyldecyl dimethyl ammonium chloride, SAMU MEDIAN Co ., Ltd .), MiKro-Quat (the principal element : 400 fold Alkyldimethylbenzyl ammonium chloride, Ecolab), and Bromo-sept (the principal element : 300 fold Di-decyl di-methyl ammonium bromide, DAE STUNG MICROBIOLOGICAL LABS . Co . . Ltd .) solutions will be used to sterilize the animal room . Each antiseptic solution will be replaced every 10 days .
5 . Analysis of contaminant in diet and H ate r (1) Diet Animals were provided ad libitirn ; with experimental rodent diet 5057 (2) Supplier Title Agri Brands Purina Korea, In c Address 627 Jangdang-dong . Pveonataek-si, Gveongoi-do, Korea P, (3) Method and amount of fodder si .ipph~ oor1402p . 2 BT Study Number: B0410 9

Report Solid fodder will be supplied freely through the fodder supplier during the study . (4) Analysis of compound and contaminant in the fodder . A certificate of analysis for the fodder was received from the Analysis Service of Central Laboratory of Purina Korea Inc . (627 Jangdang-Dong Pyongtaek Kyeonggi-Do Korea) then the tolerance level of contaminant (Biotoxtech standard) was verified .

6 . wate r (1) Typ e Purifieded water using a filter and sterilizer was provided . (2) Method of water supply Purified water in a polycarbonate bottle (500 mLl was freely supplied
. (3) Analysis and validation of compound and contaminant in drinking wate r Drinking water was collected at the fixed place by Biotoxtech, in which composition was analyzed by Chung Buk Institute of Health and Environment Research (140-50 Songjeong-Dong, Chungju-si Chungcheongbuic-Do Korea) in accordance with a 'Regulation of Quality Criteria for Potable Water and Testj (Ministry of Environment Ordinance No . 122, 2002) . Finally, every test item was evaluated whether they was in the tolerance level or not . 7 . Preparation and analysis of test substance (1) Vehicle and reason for selectio n 0 .5% MC 1500 was used, in which it was kept 4°C . This test item was recommended by the sponsor. (2) Preparation of test item The test item was dissolved in 0 .5°ro MC 1500 0 make a stock solution and was further diluted for lower concentrations . (3) Preparation of the positive contro l MMC was dissolved in Water for injection . (4) Formulation stability, homogeneity and concentration analvsi s 1~ Stability No visible generation of heat, coloring and foaming OZ Homogeneity The test substance was homogeneously dissolve d OO Concentration analysis Not done . 8 . Administratio n (1) Route Oral administration P, 

# -3 97 1 

# 06 4 

# 0 3p . 3

BT Study Number

: B04109 Report (2) Reason for selectio n Expected clinical application route for the test item was considered . (3) Injection metho d The test item and negative control were administrated by gavage ; and the positive control was by Intraperitoneal . 9 . Test group Dose Dosage Treatment Animal no

Group Route volume time s

(mg/kg ) (Identification No .)

(mL/k2) (No . ) .G1 Control 0 P .O . 10 2 6(1M01 - 1M06) G2 Low dose 500 P .O . 10 2 6(2M07 - 2M 1 2) G3 Middle dose 1000 P .O . 10 2 6(3M13 - 3M18) G4 High dose 2000 P .O . 10 2 6(4M19
- 4M2 4) Positiv e G5 control 2 I .P . 10 2 6 (5M25 - 5M30) The dose range-finding study was conducted in 5 dose levels (125, 250, 500, 1000, and 2000 mg/kg) . As a result, 2000 mg/kg was selected as the highest dose level of the main study because it did not show signs of toxicity . In addition, middle and low dose level for the main test were selected as 1,000 and 500 mg/kg, respectively . The negative control and positive control were 0 .5% MC and MMC, respectively . The closing volume of the test substance was 10 ml/kg . 10 . Observation, measurement and examination (1) General sign s All animals were observed once daily for appearance, moribund and mortality . (2) Body weight Individual body weights were recorded just before the administration and before the day for collection of the bone inarrows .
11 . Collection of bone marrow ~'00404 The dose range-finding study (Appendix 3) was carried out to determine an appropriate time for collection of the bone mariow cells at time of 16, 24 . 48 and 7 2 hours after th e %~~~~~ treatment . In results, microrucleated polychromatic ervthrocytes (ti'INPCEs) were notp . 4 BT Study Number: B04109

Report increased . Therefore, collection was done at time of 24 hour after the treatrr.ent. 12 . Collection of the bone marrow and preparation of micronucleus specimen s As a MNPCEs were not increased in the preliminary study to determine an appropriate time for collection of the bone marrow cells . To collect the bone marrow cells, mice were euthanized by dislocation of cervical vertebrae after that a 0 .2mL of fetal bovine serum (Hyclone, USA) was ran through an extracted femur using a 1 mL disposable syringe with needle and collected . Finally, collected samples were centrifuged (MICRO 17TR, Hanil science industrial) at 1,000 rpm for 5 min . The supernatant was discarded and the cell pellet was mixed well and then smeared on the slide glass . Two specimens per animal were produced, in which they were air-dried and stained with a 5 % Giemsa solution for 30 minutes
. 13 . Observation, measurement and examination (1) Observation of specimen s Each specimen was observed by the microscope (BX5 1, Olympus, Japan)with a magnification of 1,000 . To calculate the proportion of PCE in the total erythocytes [PCE/(PCE+NCE)], sum of polychromatic erythrocyte (PCE) and normochromatic erythrocyte (NCE) should be 1000 ; and to calculate MI`TCE in the Micronucleated Polychromatic erythrocyte [MNPCE/(1000PCE)], polychromatic erythrocyte (PCE) were counted as 2000 . (2) Evaluation of contro l According to the criteria of the CRC handbook of tociology (1995 by CRC Press, Inc), a negative control was judged, if MNPCE/(1000PCE) were between 0 and 8 ; and if MNPEC/(1000PCE) was increased as compared with that of the negative control, it was a positive control . . (3) Judgment criteri a It was judged as a positive when Mi~'PCEs was increased significantly in dose-dependent manner or there was reproducible increase in number of M NTPCE at least one test level . 14 . Statistics analysi s We conducted the t-test and ANOVA test for an appearance of micronucleus and body weight change with 5 % significant level in P value statistically
.



# 000405p . 5 BT Study Number: B04109

Report IV . RESULT S (1) Mortality and clinical sign s There were no dead animal and no clinical signs in the treatment groups just after the treatment . (2) Change of body weight (Table 1& Appendix 1 ) There was no significant body weight change for all test groups during the test period
. (3) Frequency of MNPCE induction (Table 2 & Appendix 2) The frequency of MNPCE induction per 1,000 PCE was 0 .3, 0 .8, 0 .8, and 1 .2 for the negative control group, 500, 1000, and 2000 mg/kg of treatment group, respectively, therefore, there was no significant induction of micronucleus in terins of the test item
. However, the frequency of M.NPCE induction in the MMC treatment group (positive control group) was average 81 .2, thus, there was significant increase as compared with that of the control group(p<0 .01) . The proportion of [PCE/(PCE+NCE)], criterion of cytotoxicity, in following dose levels 0 (negative control) ., 500, 1000, 2000 mg/kg and positive control (MMC) were 0 .498, 0 .499, 0 .495, 0 .501 and 0 .499, respectively . There was no significant difference between the treatment and control groups .



# a ;4 0 Co 0()0406p . 6 BT Study Nmnber: B04109

Report V . DISCUSSIONS AND CONCLUSION S The objective of this study was to determine a mutagenic potential of
. ~ in the micronuc'eus assay system using bone marrow cells in mice . The serial concentrations of the test item, ~ ]such as 500, 1000 and 2000 mg/kg were administered by gavages to six male mice/group . Water for injection, 10 mL/kg, was also administered by gavages to negative control group and 2 mL/kg of Mitomycin C was administered by intraperitoneal to positive control group . In 24 hour after the treatment, all mice were sacrificed then bone marrow cells in thigh were collected . The Slides containing the bone marrow cells were stained with 5% Giemsa solution . The frequency of micronucleus induction was observed by a microscope . As a result, there was no significant difference in terms of frequency of MNPCE induction between all the test groups treated wit h and the negative control group . In the positive control group, Frequency of Mi~TPCE induction was increased significantly in contrast with that of the negative control group
. The proportion of [PCE/(PCE+NCE)] was no significant difference between the treatment and control groups . Therefore, the test item, did not show the induction of micronuclei in mice under the condition of this study
.



# t?00407p . 7

BT Stud y Number: B04109

Report VI . REFERENCE S CRC handbook of toxicology(1995 by CRC Press, Inc )



# n! 4 02p . 8
BT Study Number: B04109

Report

TABLE S



# 0

~~.G'

# 4 0 a~~si 

## (.) ()0 409p . 9
BT Study Number: B0410 9 Report
Tablel . Change of body weight(Group Summary ) Hours after Groups G 1 G2 G3 G4 G5 treatment Dose(mg/kg) 0 500 1000 2000 2 Mean 35 .3 35 .3 35 .3 35 .3 35 . 3 0 S .D . 1 .1 0 .9 0 .9 0 .8 0 .8 N 6 6 6 6 6 Mean 35 .1 34 .9 34 .7 34 .6 33 . 3 24 S .D . 1 .1 1 .2 0 .8 0 .7 0 .5 N 6 6 6 6 6 G1 0 .5% MC (0 mg/kg, P .O . ) G2 : G3 : G4 : G5 : Mitomycin C (2 mg/kg, I .P .) N Number of animals examined

e L 1 .6 

## 000410P . 10

BT Stud y Number : B04109

Report Table 2 . In vivo Micronucleus test of

# C 7in male ICR mice ( Group summa ry)

Dose Sampling MNPCE/ PCE/(PCE+NCE) Groups Test items N Route 1000PCE (Mean±S .D .) (mg/kg) time ( hr) (Mean±S .D . ) G1 0 .5% MC1500 0 6 P .O . 24 0 .3± 0 .3 0 .498 ± 0 .006 G2 500 6 P .O . 24 0 .8 t 0 .4 0 .499 t 0 .005 G3 1000 6 P .O . 24 0 .8f 0 .6 0 .495f 0 .004 G4 

# J 2000 6 P .O . 24 1 .2t 0 .4 0 .5C1 ± 0 .006 G5 Mitomycin C 2 6 1 . P . 24 81 .2 ± 5 .6* 0 .499 -± 0 .003 MC 1500 Methylcellulose 150 0 N : Number of ani-nals examine d MNPCE : Micronucleated polychromat i c e rythrocyte PCE : Polychromatic e rythrocyt e NICE Normochromatic e rythrocyt e * : Significantly different from mice treated with vehicle ( P<0 .01 , t-Test)



# 000 411P . 11
BTSludy Number: B04109

Report

APPENDICES

~of ; 

## 0C► n412p . 12 BT Study Number: B04109

Report Appendix 1 . Chance of body weight (ind ;v dual, N=6) Body weight (g) at the time Groups Test items Dcse Animal I .D . of (mg/k0) Administration Sacrifice

1 M01 33 .8 34 .3 1 M02 34 .8 34 .5 1 M03 34 .8 35 . 2 G1 0 .5% Methylceilulose 1500 0 i M04 35 .7 34 .1 1 M05 35 .8 35 .1 1 M06 37 .0 37 .1 Mean 35 .3 35 .1 S .D . 1 .1 1 .1 2M07 34 .2 33 .1 2'VI08 34 .7 34 .1 2M09 34 .9 36 . 0 G2 500 2M10 35 .5 34 .9 2M1 1 36 .0 35 .0 2M12 36 .8 36 .2 Mean 35 .3 34 .9 S .D . 0 .9 1 .2 3M13 34 .3 33 .8 3M14 34 .6 33 .7 3M15 34 .9 35 . 0 G3 1000 3M16 35 .1 35 .4 3M1 7 36 .0 35 .4 3M1 8 36 .8 34 .8 Mean 35 .3 34 .7 S .D . 0 .9 0 .8 4M19 24 .4 33 .7 4M20 34 .6 34 .3 4M21 34 .9 34 . 5 G4 2000 4M22 35 .1 34 .3 4M23 36 .1 35 .5 4M24 36 .5 35 . 4 - Mean 35 .3 34 .6

S .D . 0 .8 0 .7 5M25 34 .5 33 .2 5M26 34 .5 33 .0 5M27 34 .9 33 . 5 G5 Mitomycin C 2 5M28 35 .1 32 .5 5M29 36 .1 33 .8 5M30 36 .4 33 .5 Mean 35 .3 33 .3 S . D . 0 .8 0 .5 N Number of animals examined U 11) 7 ;liP 'Q~413p . 13 BT Study Number: B04109

Report Appendix 2 . In vivo Micronucleus test of ~ In

male ICR mice (Individual, N=6 ) Groups Test items Dose Route Samclina Animal Counted PCE/ MNPCE/ (mg/kg) time (hrs) 1 . D . PCE : NCE (PCE+NCE) 1000PCE 1 M01 500 : 500 0 .5000 0 .5 1M02 491 : 509 0 .49~ 0 . 5 1 M03 492 : 5C8 0 .492 0,0 0 .5 % G1 Methylcellulose 0 P .O . 24 1 M04 498 : 502 0 .498 0 .0

1500 1 M05 506 494 0 .506 0 .5 1 M06 501 : 499 0 .501 0 .0 Mean 0 .498 0 .3 S . F) 0 .006 0 .3 2M07 496 504 0 .496 1 .0 2MC8 492 508 0 .492 1 .0 2MC9 503 497 0 .503 1 . 0 G2 7500 P .O . 24 2M10 504 496 0 .504 0 .0 2M11 498 • 502 0 .498 1 .0 2M12 501 : 499 0 .501 1 .0 Mean 0 .499 0 .8 S,D 0 .005 0 .4 3M' 3 489 : 511 0 .489 1 .0 3M14 500 : 500 0 .500 0 .0 3M15 495 505 0 .495 1 . 5 G3 1000 P .O . 24 3M16 492 508 0 .492 1 .0 3M17 497503 0 .497 1 .0 3M18 494 506 0 .494 0 .0 Mean 0 .495 0 .8 S .D 0 .004 0 .6 4M19 508 : 492 0 .508 1 .5 4M20 504496 0 .504 0 .5 4M21 501 : 499 0 .501 1 . 0 G4 72000 P .O . 24 4M22 490510 0 .490 1 .5 4M23 504 : 496 0 .504 1 .5

--~ 4N24 497503 0 .497 1 . 0 Mean 0 .501 1 .2 S .D 0 .006 0 .4 5M25 496 : 504 0 .496 79 .5 5h126 497 : 503 0 .L97 74 .5 51%127 502 : 498 0 .502 81 .0 5 M G5 Mitornycin C 2 1 . P . 24 5M28 495 ~ 505 0 .495 90 .0 5M29 501 499 0 .501 85 .0 5M30 502 498 0 .502 77,0 Mean 0 .499 81 .2 S .D 0,003 5 .6 MNPCE Micronucleated polychromatic erythrocyt e PCE : Polychromatic erythrocyt e NCE : Normochromatic erythrocyte .js i~~}14 N : Number of animals examinedp . 14
BT Study Number

: B04109 Report Appendix 3 . Result of prelirnirary test(N=3 ) Test item Dose Route Sampling Animal ID MNPCE/ MNPCE/

(mg /kg) time (hrs) 2000PCE 1000PCE BM01 3 .0 1 .5 BM02 2 .0 1, 0 P .O . 16 BM03 2 .0 1 .0 Mean 2 .3 1 .2

_ S .D . 0 .6 0 . 3 BM04 3 .0 1 .5 BM05 3 .0 1 .5 P .O . 24 BM06 2 .0 1 . 0 Mean 2 .7 1 .3 2000 - S .D . 0 .6 0 .3 BM07 2 .0 1 .0 BM08 1 .0 0 . 5 P .O . 48 BM09 2 .0 1 .0 Mean 1 .7 0 .8 S .D . 0 .6 0 .3 BM10 2 .0 1 .0 BM11 3 .0 1 . 5 P .O . 72 BM12 3 .0 1 .5 Mean 2 .7 1 .3 S .D . 0 .6 0 .3 N : Number of animals examine d MNPCE Micronucleated polychromatic erythrocyte PCE : Polychromatic erythrocyte



## 00t1415p . 15
BT Study Number: B04109

Report Appendix 4 . Certificate of analysi s

CERTIFICATE OF ANALYSIS
1 . TEST MATERIAL IDENTIFICATION (1) TEST MATERIAL LOT No . : (2) QUANTITY ~ l00 g (3) PRODUCER ADDRESS • ) an Tel No . (4) CHEMICAL NAME(CAS No . if available ) 

# E

~ (5) PURITY ~ About 100 % (6) APPEARANCE ~ Orange so li d 2 . SOLUBILIT Y (1) INSOLUBLE ~ Water (2) SOLUBLE ~ DIviSO, Acetone 3 . Storage temperature : Below 30degC 4 . Stability ~ Stable We hereby certify that the data stated here above are true and correct. 18 Apr 200 4 Signature

~ 71 . n AT 

## 0 {.~~ 

## 416p . 16

~ ~ - -

September 21, 2004 Document Control Officer - f'any Sanirized Office of Pollution Prevention and Toxic Substances, 740 7 

### U .S . EPA Ariel Rios Bldg . 

### 1201 Constitution Ave . NW Washington, DC 2046 0 Re : Premanufacture Notices P 04-346, -347 : Additional Toxicity Report Dear Sir or Madam : On behalf of [ ] is submitting an additional toxicity study, In Vivo Micronucleus Test in Mice, for P 04-346, -347 . Accordingly, amended PMN pages 1 and 12 are included . The PMN review period for these new substances has been suspended so that a 5(e) consent order can be developed . This submission does contain confidential business information (CBI) . Confidential and sanitized copies of the study are included
. 

### If there are any questions regarding this SubmlSS1o11, please do not hesitate to contact me at [ ] . r_ c~ Sincerely ,



### [ ] _ ~ Attachments c7 c. .~ 

# ILIJHll LIll 0 0 5 71 9 1 S 0 

# ijU 3~p . 1 7 Form Approved . O .M .B . No . 2070-0012 . Approval Expires 10-31-96 . U .S . ENVIRONMENTAL PROTECTION AGENCY AGENCY USE ONLY Dare of receipt 

## PREMANUFACTURE NOTICE \

# W EPA FOR NEW CHEMICAL SUBSTANCES i When %iiiiiW- DOCUMENT CONTROL OFFICE R completed OFFICE OF POLLUTION PREVENTION -' )17?(1~rj V '~'~I~~~ send this AND TOXIC SUBSTANCES, 740 7 o to U .S . E .P .A . 401 M STREET, S W WASHINGTON, D .C . 20460 Enter the total number of pages 416 Document connol nt .mber EPA case number in the Premanufacture Notice GENERAL INSTRUCTIONS TS _ 0 4 A 11 K 11 N 1 • You must provide all information requested in this form to the extent that it is known to or reasonabl% ascertainable by you . Make reasonable estimates if you do not have actual data . • Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual is available from the Toxic Substances Control Act (TSCA) Information Service by calling 202-554-1404, :)r faxing 202-554-5603) . • Ifa user fee has been remitted for this notice (40 CFR 700 .45), indicate in the b :)xes abo~e the TS-user fee identification number you have generated . Remember, your user fee ID number must also appear on your corresponding fee remittance, w hich is sent to EPA, HQ Accounting Operations Branch (PM-226), P 0 . 360399 M. Pittsburgh, PA 15251-6399, Attn . TSCA User fee . Part [-GENERAL INFORMATION TEST DATA AND OTHER DAT A You must provide the currently correct Chemical Abstracts (CA) Name of the new You are required to submit all test data in your possession or control and to provide a chemical substance, even if you claim the identity as confidential . You may authorize description of all other data known to or reasonably ascertainable by you, if these another person to submit chemical identity information for you, but your submission w ill data are related to the health and environmental effects on the manufacture , not be complete and the review will not begin until EPA receives this information . A processing, distribution in commerce, use, or disposal of the new chemical letter in support of your submission should reference your TS user fee identification substance . Standard literature citations may be submitted for data in the open number. You must submit an original and two copies of this notice including all test data . If you claimed any information as confidential, a single sanitized copy must also be scientific literatur_ . Complete test data (written in English), not summaries of data submitted
. must be submittec if they do not appear in the oeen literature . You should clearly identify whether test data is on the substance or on an analog . Also, the chemical composition of th : tested material should be characterized . Following are example s Part II- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE of test data and other data . Data should be submitted according to the requirements of §72050 of the Premanufacture Notification Rule (40 CFR Part 720)
. If there are several manufacture, processing, or use operations to 'De described in Part It, sections A and B of this notice, reproduce the sections as needed . Part Ill - LIST OF A TTACFLNIENTS Test Data (Check 3elov, any included in this notice) Attach additional sheets if there is not enough space to answer a question fully . Label E wirenn :ental face data ® Yes Other data Z Yes each continuation sheet with the corresponding section heading . In Part III, list thes e attachments, any test data or other data and any optional information included in the Health effects data E Yes Risk assessments notice . E vironmental effects data Yes Structure/activity relationships Physical/Chen-ical Properties' Yes Test data not in the possession OPTIONAL INFORMAT[ON or control of the submitter You may include any information that you want EPA to consider in evaluating the new A physical and chemical propecies worksheet is located on the last page of this fomt

. substance . On page I 1 of this form, space has been provided for you to described pollution prevention and recycling infomtation you may have regarding the new TYPE OF NOTICi -_ (Check Only One) substance . PMN (Premanufacture Notice) So-called "binding" boxes are included throughout this form for you to indicate you r willingness to be bound to certain statements you niake in this section, such as use , production volume, protective equipment . . . This option is intended to reduce delays ❑ INTERMEDIATE PMN (submitted in sequence with final product PMN) that routinely accompany the development of consent orders or Significant New Use Rules . Except in the case ofexentption applications (such as TMEA, LVE, LOREX) r❑ SNC'N 1Significant New Use Notice) c where certain infomtation provided in such notification is binding on the submitter whe n the Agency approves the exemption application, checking a binding box in this notic e does not by itself prohibit the submitter front later deviating from the information (except ❑ TMEA (Te :,t Marketing Exemption Applicauon) chemical identity) reported in the form = ❑ LVE (Low Volume Exemption) @40 CFR 723 .50(c)(14 CONFIDENTIALITY CLAIMS - You may claim any information in this notice as confidential . To assert a claim on the ❑ LORE\ (La v Releasc'Low Exposure Eten c[ion) ii 44) l7FR 723 .50(c)(2 ) fomr, niark (X) the confidential box next to the intbrmation that you claim a s confidential. To assert a claim in an attachment, circle or bracket the information you ❑ LVE Modification LOREN aaim as confidential. If you claim information in the notices as confidential . you mus t also provide a sanitized version of the notice . (including attachments) . For additional IS T .IfS A CONSOLIDATED P\1N? ® y ! .1

~ instructions on claiming information as confidential, read the Instructions Manual . Ye , ® 4 of chemicals 2

Mark (x) ifany infonnation in this notice is claimed as confidential . (E'renonce Cotnn•,unica :iou r required, enter # on page 3 ) E?A FORM 7710-25 (Rev . 5-95) Replaces previous editions of EPA Form 7710- 2 5 .p . 18 `-- .

^~ .r . . . . . r.. . . June 15, 2004 Document Control Officer 

### Office of Pollution Prevention and Toxic Substances, 7407 U .S . EPA Ariel Rios Bldg . 1201 Constitution Ave . NW Washington, DC 2046 0 Re : Premanufacture Notices P 04-346, -347 Regulatory Option Choice 

### Dear Sir or Madam : On behalf of [ ] is submitting the "SELECTION OF REGULATORY OPTION" form related to the non-negotiated section 5(e) consent order for P 04-346, -347 . This submission does contain confidential business information (CBI) . A confidential and a sanitized copy of the cover letter and form are included . If there are any questions regarding this submission, please do not hesitate to contact me at [ ] . 

### Sincerely,

~

[ ] - . . . Attachments ` 

### .F-

~ 

# ~,o~pany ianl

# t! ~~~~ 111~~

# Ilifi 1111~ H11 

# ~ 1111~ 11111 1E1

# ~ 1~ 11 5 0 0 4 0 0 0 4 0 4 0/ S



## ,Q-j ►t~l,p.P . 19

SELECTION OF REGULATORY OPTION FOR PMN # P-04-346/347 I have reviewed the Agency's letter dated which outlines the regulatory options for the above-referenced PMN, and I select the following option: Option 1
- Non-negotiated section 5(e) Consent Order

(60-day suspension recommended) ❑ Option 2 - Negotiated section 5(e) Consent Order

(90-day suspension reconunended ) ❑ Option 3
- Upfront submission of specified data before commencemen t of manufacture (suspension as appropri ate) ❑ Option 4
- Upfront submission ofother information before commencement of manufacture

(suspension as appropriate) ❑ Option 5- Withdrawal of PMN per 40 CFR 720.75(c)

(no suspension necessa ry) To provide time for implementation of the selected option, I re quest, pursuant to 40 CFR 720 .75(b), a suspension of the PMN review period for 60 days or until the following date :

_, . 

# D6/~~/°~ I _ Date

TOTAL P .08i5 .-1 FPri~ 17/i2

~ March 5, 200 4



### Document Control Office r Office of Pollution Prevention and Toxic Substances, 7407 U .S . EPA 

### Ariel Rios Bldg . 1201 . Constitution Ave . NW Washington, DC 2046 0 Re : Premanufacture NoticeTS-04ATZ.ti1 - P 04-346, -347 Corrections Dear Sir or Madam : On behalf of [



### ] is submitting corrected PN'[N pages 5 and 5B for Prcmanufacture Notice TS-04A~N1 - P 04-3,46, -347 . In the original submission, EPA noticed inconsistencies in the polymer molecular weight data found on pages 5 and 5B compared to polymer molecular weight data found in the attachments . has revie,,ved the discrepancies and now reports that one grade of the new polymer was used for toxicity testing while molecular weight data from another o ace was placed in the original PMN form . To date, [ ] has developed three different gradcs of the polymer, which, it ' intends to offer for commercial purposes : r'- ~_ -i : 

### The corrected PMN pages 5 and 5B now contain the lowest average molecular =- - weight information for the new polymer while the original pages did not . The GPC data found on PMN page 21 is associated with polymer grade (1) . This PMN correction does contain confidential business information (CBT) . The confidential PMN corrections and two copies are enclosed for EPA review as well as a sanitized copy . If there are any questions regarding this submission, please do not hesitate to contact me at [ ) . 

### Sincerely, [ ] Attachments 

# IIIJflfl LIfl 11111 

# IIfl IiIII 1 1

# JOI~~ 11 

# II l 0 

# LIfl[Il l 4



## ~~ P

## r111